Biologic fluid sample analysis cartridge

• US 8,797,527 B2
• Filed: 08/24/2012
• Issued: 08/05/2014
• Est. Priority Date: 08/24/2011
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hukari, Kyle, Nikonorov, Igor, Dowdell, Ralph W., Olson, Douglas, Lalpuria, Niten V., Unfricht, Darryn, Ports, Benjamin, Phan, Vu, Levy, Robin A., Roche, John W.
• Primary Examiner(s): NGUYEN, SANG H
• Application Number:
  US13/594,439
• Publication Number:
  US 20130114075A1
• Time in Patent Office: 711 Days
• Field of Search: 356/244, 356/246, 422/68.1, 422/400, 422/430, 422/88, 435/287.2, 436/43, 436/168
• US Class Current: 356/246
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0652 Sorting or classification of particles or molecules
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/142 Preventing evaporation
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0858 Side walls
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/0883 Serpentine channels
• CPC Class Codes: B01L 2300/089 Virtual walls for guiding liquids
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/024 touch-off at the side wall of the receptacle
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0457 : passive flow or gravitation
• CPC Class Codes: B01L 2400/086 : using baffles or other fixed flow obstructions
• CPC Class Codes: B01L 2400/088 : by specific surface properties
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502738 : characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 9/527 : for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 21/01 : Arrangements or apparatus for facilitating the optical investigation

Abstract

A biological fluid sample analysis cartridge, analysis system, and method for analyzing a biologic fluid sample are provided. The cartridge includes a collection port, at least one channel within the cartridge in fluid communication with the collection port, a passage in fluid communication with the at least one channel, and an analysis chamber mounted on a tray. The tray is mounted relative to the cartridge and selectively positionable relative to the passage in a first position where the analysis chamber will engage a bolus of sample extending out from the passage to permit selective transfer of sample from the bolus to the analysis chamber.

Claims

1. A biological fluid sample analysis cartridge, comprising:

a collection port;

at least one channel within the cartridge in fluid communication with the collection port;

a passage in fluid communication with the at least one channel; and

an analysis chamber mounted on a tray, which tray is mounted relative to the cartridge and selectively positionable relative to the passage in a first position where the analysis chamber engages a bolus of sample extending out from the passage to permit selective transfer of sample from the bolus to the analysis chamber, and positionable in a second position within the cartridge and in the second position the analysis chamber is separated from the passage.

2. The cartridge of claim 1, wherein the passage includes a first end and a second end, and which first end is in fluid communication with the at least one channel, and which second end is configured to permit the formation of a bolus of sample extending out from the second end.

3. The cartridge of claim 2, wherein the analysis chamber includes a base chamber panel and an upper chamber panel, separated from one another by a chamber height, and each of the panels includes a sample entry edge.

4. The cartridge of claim 3, wherein the sample entry edges of the panels are substantially aligned with one another.

5. The cartridge of claim 3, wherein in the first position the tray is mounted relative to the cartridge so that at least one of the sample entry edges of the analysis chamber engages the bolus of sample extending out from the second end of the passage.

6. The cartridge of claim 2, wherein at least the first end of the passage has a slot configuration with a major axis and a minor axis, wherein the major axis is larger than the minor axis.

7. The cartridge of claim 2, wherein the passage is at least partially disposed within an interface post.

8. The cartridge of claim 7, wherein the interface post includes a surface disposed at the second end of the passage, which surface is oriented to gravitationally support at least a portion of the sample bolus.

9. The cartridge of claim 7, wherein the interface post includes a V-shaped slot intersecting with the second end of the passage.

10. The cartridge of claim 2, wherein the analysis chamber is defined by a base chamber panel, an upper chamber panel, and a plurality of lateral boundaries, and wherein the lateral boundaries than a first opening and second opening, and wherein the first opening is larger than the second opening.

11. The cartridge of claim 10, wherein the base chamber panel has an interior surface, and the upper chamber panel has an interior surface, and at least one of the lateral boundaries contacts both interior surfaces.

12. The cartridge of claim 11, wherein the lateral boundaries are configured to create a circuitous path between the first opening and the second opening.

13. The cartridge of claim 11, wherein the analysis chamber includes a plurality of sub-chambers founed by the lateral boundaries.

14. The cartridge of claim 2, further comprising a secondary analysis chamber in fluid communication with the at least one channel.

15. The cartridge of claim 14, wherein the secondary chamber has a first portion having a first height, and a second portion having a second height, which second height is greater than the first height, and a difference between the two heights is known.

16. The cartridge of claim 2, wherein the at least one channel includes an initial channel in fluid communication with the collection port, and a secondary channel having a first end in fluid communication with the initial channel and a second end in fluid communication with the passage.

17. The cartridge of claim 1, wherein a biasing structure maintains the tray in the second position and in the first position the biasing structure biases the tray toward the second position.

18. The cartridge of claim 17 wherein the tray includes the biasing structure.

19. The cartridge of claim 17, wherein the biasing structure is a tray clip operable to maintain the tray in the second position.

20. The cartridge of claim 19, wherein the tray clip is V-shaped and includes a first arm, a second arm, and a center void disposed between the first and second arms.

21. The cartridge of claim 1, further comprising a fluid actuator port configured to engage a sample motion system and to permit a fluid motive force to access the cartridge to cause the movement of fluid sample within the at least one channel.

22. The cartridge of claim 21, wherein the fluid actuator port includes a rupturable seal material.

23. The cartridge of claim 1, further comprising a cap operable to cover and seal the collection port.

24. The cartridge of claim 1, further comprising an analysis chamber window configured to allow visual inspection of the analysis chamber disposed in the first position.

25. The cartridge of claim 1, wherein the tray is configured to engage an actuator operable to selectively move the tray relative to the cartridge.

26. The cartridge of claim 1, wherein the cartridge includes a pocket configured to receive the tray.

27. The cartridge of claim 26, wherein the tray is configured to engage an actuator operable to selectively move the tray into and out of the pocket.

30. The cartridge of claim 2, wherein the at least one channel includes the passage.

28. A biological fluid sample analysis cartridge, comprising:

a collection port;

at least one channel within the cartridge in fluid communication with the collection port;

a passage in fluid communication with the at least one channel; and

an analysis chamber mounted on a tray, which tray is mounted relative to the cartridge and selectively positionable relative to the passage in a first position where the analysis chamber engages a bolus of sample extending out from the passage to permit selective transfer of sample from the bolus to the analysis chamber;

wherein the passage includes a first end and a second end, and which first end is in fluid communication with the at least one channel, and which second end is configured to permit the formation of a bolus of sample extending out from the second end; and

wherein the at least one channel includes an initial channel in fluid communication with the collection port, and a secondary channel having a first end in fluid communication with the initial channel and a second end in fluid communication with the passage; and

wherein the initial channel has a cross-sectional area sized such that sample travels by capillary force within the initial channel and the secondary channel has a cross-sectional area sized such that sample cannot travel by capillary force within the secondary channel.

29. The cartridge of claim 28, wherein the initial channel includes a constricted section adjacent an interface with the secondary channel, and the constricted section is configured such that the cartridge can be oriented with the initial channel gravitationally vertical and fluid within the constricted section will not travel from the constricted section into the secondary channel absent externally applied motive force.